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Extended Interval Dosing of Gentamicin in Neonates to Achieve Target Drug Concentrations

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

A previous pharmacy residency project was done 20 years ago looking at the best dosing for the antibiotic gentamicin for babies up to 7 days old. This study showed that giving the dose less often leads to better drug concentrations than giving the dose more often. Our gentamicin dosing at the Children's Hospital at London Health Sciences Centre is based on the better dosing from the study. This dosing is gentamicin 3 mg/kg every 24 hours for babies less than 35 weeks gestational age and 3.5 mg/kg every 24 hours for babies at least 35 weeks gestational age. These results were never published. Different dosing is used at different hospitals. It is important that we check that our gentamicin dosing is still reaching safe and effective drug concentrations in the current study. The study will look at the gentamicin drug concentrations of babies up to 7 days old, including premature and term babies. We will also confirm if the babies have kidney or hearing damage from gentamicin. We will compare the gentamicin drug concentrations from this study to the past data to see if the dosing is still the best. The results can help form a guideline for the Children's Hospital and surrounding hospitals.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 7 days
Healthy Volunteers: f
View:

• Neonates up to 7 days of age,

• Neonate must be on gentamicin, and

• Gentamicin trough and peak levels must be available for the third dose of gentamicin.

Locations
Other Locations
Canada
Children's Hospital: London Health Sciences Centre
RECRUITING
London
Contact Information
Primary
Sarah H.P. Vo, PharmD
sarah.vo@lhsc.on.ca
519-685-8500
Time Frame
Start Date: 2026-06
Estimated Completion Date: 2027-04
Participants
Target number of participants: 42
Treatments
Neonates less than 35 weeks gestational age
Neonates at least 35 weeks gestational age
Related Therapeutic Areas
Sponsors
Leads: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

This content was sourced from clinicaltrials.gov